Recruiter: Spencer Gregory Hale
Senior Software Quality Engineer – Global Device Software Steward Support
Travel amount: Up to 10%
Remote Eligible: Hybrid
Onsite Location(s): Hybrid in MN
About the role:
This Device Software Sub-Process Steward Support role teams with the Device Software Sub-Process Steward to help with leadership and oversight to the Device Software sub-process. The Device Software sub-process controls device software considered a finished medical device or used as a component, part, or accessory of a medical device developed, subcontracted, modified, or purchased. Quality System Stewards use the Best4 (Culture, Agility, Performance, Compliance) Strategy to enable our Quality Policy. Global Quality System Device Software sub-process maintain oversight of all processes in their assigned Sub-Process. Sub-Process Stewards work together to maintain their assigned Process(es) and ensure all responsibilities are fulfilled.
Your responsibilities will include:
Best Culture:
Sustain Device Software Community of Practice (CoP).
Provide subject matter expertise for the organization and collaborate with site/divisional experts.
Write applicable annual quality goals and objectives with input from sites, divisions, regions, and leadership to align with Best4 and organizational strategies. Support and update goals and objectives throughout the year.
Best Agility:
Monitor Device Software Sub-Process and implement process improvements based on performance feedback.
Drive value improvement projects (VIP) to support organizational goals.
Support acquisition integration as needed.
Increase Quality System simplicity, efficiency and predictability with standardization and lean practices.
Maintain and enhances internal and external relationships in support of the Global Quality System Process/Sub-Process.
Best Performance
Monitor and mitigate Quality System Process compliance risk where appropriate.
Lead or oversee quality projects of major magnitude and scope. Provide input to overall quality project portfolio and project priorities.
Determine if changes are reportable to notified bodies.
Initiative corporate preventive CAPAs and own or participate in corporate preventive CAPA teams.
Create, implement, and sustain measures and metrics to monitor Device Software Sub-Process health.
Provide metrics, data and analysis for management review.
Best Compliance:
Establish and maintain Global Quality System Device Software Sub-Process to ensure compliance with applicable quality and regulatory requirements.
Review of new Laws Regulations Standards and Guidance’s (LRGS) and the implementation of new requirements into the BSC Quality System.
Communicate new and updated requirements.
Provide subject matter expertise and support for corporate and site internal and external audits. -
Review quarterly data per Quality System Process Compliance Assessment.
Support the audit non-conformance response strategies.
Identify Global Quality System Device Software Sub-Process training requirements.
Support corporate NCEP & CAPA Processes.
Assess reportability of substantial Quality System Changes.
Ensuring quality records are created, maintained and dispositioned.
Required Qualifications:
Bachelor’s level degree in Science/Engineering/Computer Science/Software Engineering discipline and/or Minimum of 4 years of related experience in the Medical Device regulated industry.
Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, IEC 62304; ISO 14971; FDA Guidance – General Principles of Software Validation and Computer Software Assurance for Production and Quality System Software.
Must have good understanding of quality system requirements and how each quality system element connects.
Comfortable speaking and presenting to leadership
Strong written and verbal communication skills in English
Experience managing projects and project deliverables to completion
Comfortable working independently and as part of a cross-functional team
Ability to manage multiple priorities
Proficient in Microsoft Office
Works willingly and effectively with others in and across the organization to accomplish team goals with excellent interpersonal and networking skills.
Values people’s opinions and encourages knowledge sharing. High level of energy, drive and enthusiasm
Knowledge of Software Engineering Principles and Software Development Life Cycle (SDLC)
Ability to work independently and collaborate with cross-functional teams to complete projects
Strong critical thinking and analytical skills: process and results-oriented
Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively
Preferred Qualifications:
Device Software Engineering Experience, including:
Device Software Development
Device Software Testing / Verification
Risk Management
Cybersecurity
Artificial Intelligence / Machine Learning
Agile Practices
Experience in supporting and enhancing the QMS processes including:
Device Software Development
Design Controls
Risk Management
Post Market and Premarket Cybersecurity
Experience working with Medical Device Software Advocacy, Standards and Professional Organizations (i.e. AAMI; MDIC; IEC; FDA; AdvaMed; NIST; IMDRF)
Formal Project Management Experience
CAPA, Vendor Controls, Complaint Handling and Internal/External Audits Experience
Software Development Tools Experience (i.e. Jira; Cockpit; Github; Codenvy; Bitbucket)
Requisition ID: 630662
Minimum Salary: $ 85000
Maximum Salary: $ 161500
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Skills Required
- Bachelor's degree in Science/Engineering/Computer Science/Software Engineering discipline and/or minimum 4 years related experience in the Medical Device regulated industry
- Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, FDA Guidance (Software Validation and Computer Software Assurance)
- Understanding of quality system requirements and how each quality system element connects
- Comfortable speaking and presenting to leadership; strong written and verbal communication skills in English
- Experience managing projects and project deliverables to completion; formal project management preferred
- Ability to work independently and as part of a cross-functional team; ability to manage multiple priorities
- Proficient in Microsoft Office
- Knowledge of Software Engineering Principles and Software Development Life Cycle (SDLC)
- Strong critical thinking, analytical, organizational skills; detail oriented; ability to multi-task and prioritize
- Works effectively across the organization with strong interpersonal and networking skills; values knowledge sharing
Boston Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
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Retirement Support — Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
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Leave & Time Off Breadth — Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.
Boston Scientific Insights
What We Do
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.
